Factor VIII (8) Inhibitor Titer – Chromogenic (Nijmegen-modified Bethesda assay)

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Justification

Acquired factor deficiencies may occur due to the development of factor-specific inhibitory antibodies. These antibodies may also develop against factor replacement products in patients with a congenital deficiency. This test may be used to detect and quantitate inhibitory antibodies against Factor VIII. This assay is suitable for the detection of Factor VIII inhibitors in patients on the recombinant, monoclonal antibody treatment Hemlibra (emicizumab).

STAT: < 24 hours (M-F)

Bethesda, Chromogenic

Draw Tube: Blue Top

Sample Type: Citrated Plasma

Specimen Requirements

	Sample Type	Volume Required	Minimum Volume	Stability
PREFERRED	Citrated Plasma	Two aliquots, 1mL each	Two aliquots, 0.5mL each	Frozen (-20C): 2 weeks Frozen (-80C): 6 months
ALTERNATIVE	-	-	-	-

REJECTION CRITERIA	Thawed in transit, refrozen or clotted sample
SPECIAL INSTRUCTIONS	-

General Information

METHODOLOGY	Bethesda, Chromogenic
STAT TAT	< 24 hours (M-F)
STAT TAT Performance	> 90% of results released in 24 hours
ROUTINE TAT	< 3 days (M-F)
ALTERNATIVE NAMES	Chromogenic Factor VIII (8) Inhibitor Titer, Factor VIII (8) Inhibitor Titer - Hemlibra specific, F8 chromogenic inhibitor, FVIII chromogenic inhibitor
DESCRIPTION	Nijmegen-modified Bethesda titer for the quantitative determination of a specific factor inhibitor against factor VIII (8).
LIMITATIONS	-
NORMAL RANGE	< 0.4 NBU
ASSOCIATED TESTING	-
REFERENCES	-
SAMPLE REPORT	Upon request
NEW YORK STATE APPROVED	No

Test Codes

ORDER CODE	P3383
CPT CODE	85240, 85335
LOINC CODE	3204-5, 3209-4